Abstract P6-05-12: Understanding Patient Perspectives on Window of Opportunity Clinical Trial Participation in Breast Cancer
Authors: Vanessa Lopez Ozuna, Gregory R. Pond, John MS Bartlett, Lazlo Radvanyi, Melanie Spears, Teresa Petrocelli, Carol Gordon, Rebecca J. Rose, Angel Arnaout
Journal: Cancer Research (2023)

Abstract Background: Window of opportunity (WOO) clinical trials take advantage of the waiting period between a patient’s cancer diagnosis and standard treatment (usually surgery) to evaluate novel cancer therapies and their biologic effects in vivo. These types of trials are being increasingly harnessed in the clinical setting for the safe and rapid evaluation of novel therapeutic strategies in treatment naive patients, thereby expediting drug development. Distinct from neoadjuvant trials, no therapeutic benefit is envisaged and the patient’s standard treatments are not intentionally delayed. The purpose of this study was to understand the patient motivations and perspectives for participating in WOO trials. Methods: This study was conducted at an academic cancer center where two breast cancer WOO trials were ongoing (NCT04781725 and NCT04676516). Eligible patients with newly diagnosed operable invasive breast cancers participating in either of these WOO trials were recruited to this separate study. Patients were provided with a questionnaire that surveyed their motivation and perspectives for participation or lack of participation in the WOO trial Results: From April 2021- May 2022, the study recruited 89 patients with age ranging from of 40-78 yrs with tumors ranging from 1.5-4.3 cm. Surgical wait times ranged from 2-8 weeks. Of the 83 patients that participated in a WOO trial, the most common reasons for participation included (a) the potential to benefit other patients in the future (90%) (b) trust in their treating doctor (88%), (c) desire to contribute to scientific research (62%) and (d) a belief that they may benefit from the therapy (39%). For these patients, 49% reported that the possibility of a repeat biopsy would not deter them from trial participation; whereas 11% said that it definitely would. Of the 6 patients that chose not to participate in a WOO trial the most common reasons included (a) travel or transportation issues (50%) and (b) lack of belief of potential benefit to them (33%). For these patients, when asked whether the participation of a cancer patient in the design of the WOO trial would change their mind, all reported that it would not make a difference. Conclusion: WOO trials are becoming increasingly common in oncology research. Understanding patient perspectives for WOO trial participation is useful to inform trial design and communication approaches in future WOO trial efforts. Citation Format: Vanessa Lopez Ozuna, Gregory R. Pond, John MS Bartlett, Lazlo Radvanyi, Melanie Spears, Teresa Petrocelli, Carol Gordon, Rebecca J. Rose, Angel Arnaout. Understanding Patient Perspectives on Window of Opportunity Clinical Trial Participation in Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-05-12.